gcsr sem 4

21
A. Description of Business GUJARAT LIQUI PHARMACAPS (PVT) LIMITED (GLPL) is a leading Indian Pharmaceutical company specializing in Novel Drug Delivery System of Soft Gelatin Capsules & having its state- of-the-art Manufacturing Facility at Gujarat, India. We are an Export Oriented WHO approved, ISO 9001: 2008 for Quality Management Systems & ISO 14001: 2004 for Environmental Management Systems certified company with STAR EXPORT HOUSE STATUS. We have been awarded the prestigious SME GAURAV AWARD-2011, instituted and given by D&B and Axis Bank for Entrepreneurial Excellence in Business, Operations, Finance and Quality of the Management. We manufacture, market and distribute these Formulations, some of them being life saving, around the world. In addition, we have our foray in other dosage forms as well. Our special focus on Research, Development of new formulations and validating their Methods of Analysis have made us so unique in Soft Gels in such a short time in the rapid changing scenario of Pharmaceutical world. We played a pioneering role in developing some of the formulations for the first time in the world in Soft Gelatin dosage form. We have got our global presence around the world. As an Organization, we attach immense importance and significance to learning and being emotionally intelligent. We also want us to be seen and known as an institution genuinely supporting multi-racial harmonious co-existence

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Page 1: Gcsr SEM 4

A. Description of Business

GUJARAT LIQUI PHARMACAPS (PVT) LIMITED (GLPL) is a leading Indian

Pharmaceutical company specializing in Novel Drug Delivery System of Soft Gelatin

Capsules & having its state-of-the-art Manufacturing Facility at Gujarat, India. We are an

Export Oriented WHO approved, ISO 9001: 2008 for Quality Management Systems

& ISO 14001: 2004 for Environmental Management Systems certified company with

STAR EXPORT HOUSE STATUS. We have been awarded the prestigious SME

GAURAV AWARD-2011, instituted and given by D&B and Axis Bank for

Entrepreneurial Excellence in Business, Operations, Finance and Quality of the

Management.

We manufacture, market and distribute these Formulations, some of them being life

saving, around the world. In addition, we have our foray in other dosage forms as well.

Our special focus on Research, Development of new formulations and validating their

Methods of Analysis have made us so unique in Soft Gels in such a short time in the

rapid changing scenario of Pharmaceutical world. We played a pioneering role in

developing some of the formulations for the first time in the world in Soft Gelatin dosage

form. We have got our global presence around the world.

As an Organization, we attach immense importance and significance to learning and

being emotionally intelligent. We also want us to be seen and known as an institution

genuinely supporting multi-racial harmonious co-existence and living our lives with

paradigms shifted and boundaries of limitations removed!

Like Dr. Kalpana Chawla, we also believe “The path from dreams to success does exist”,

we hope that “you have the vision to find it, courage to get on to it and the perseverance

to follow it”.

Page 2: Gcsr SEM 4

Our Vision

Be global and remain local.

Build a motivated institution of competent persons and expand our knowledge

base.

Strive relentlessly for excellence in every sphere of our activities through

continual up-gradation of knowledge.

Nurture environment, conserve energy and support human lives with our serious

healthcare efforts.

Our Mission

Business Excellence : Through delighted Customers with long term Win-Win-

Win relationships and Technological innovations.

Nurturing Human Assets : By providing an open and challenging Working

Environment charged with Passion and aided by Emotional Intelligence.

Responsible Corporate Citizenship : Through Conservation of Energy and

providing support to our Mother Nature

Our Business

We have dedicated our business initiatives to a Novel Drug Delivery System i.e.

Soft Gelatin Pharmaceutical Formulations having immense unexplored potential

for offering better drug efficacy in alleviation of human suffering and misery.

Our business is structured mostly in following 02 categories.

Page 3: Gcsr SEM 4

Exports :

Have our Sales & Marketing offices in different countries of Africa, South East

and Central Asia and also operate for our buyers in UK, Arab world and South

America.

Domestic :

We have got limited but significant operational presence for ethically Marketing,

Selling and Distributing our Medicines in Indian states of Gujarat, MP &

Chattisgarh and Rajasthan.

We also outsource Pharmaceutical formulations of other Dosage Forms like

Tablets, Capsules, Injectibles and ointments and market them under our strict

Quality Control Vigilance.

Very strong Formulation Developmental initiatives support and reinforce our

Business Operations.

Page 4: Gcsr SEM 4

SWOT analysis of the company:

Strength

Technological skill

Leading brands

Production quality

Focus only Gelatine Capsules

only

Wide international market

Vast market growth potential

Strong local manufacturing

sector

Strong brand presence in

African market

Good marketing and

distribution system

Weakness

High transaction costs

Weak focus on process

innovations

High computation from

many Indian and other

global brands.

Lack of data protection

Opportunities

Liberalization of geographic markets

Changes in government politics

Entering into domestic market

Rising demand for generic drugs

globally

Venturing towards areas of

cardiology and anti-cancer

Scope for expansion and additional

units for generic drugs.

Threats

There is growing

competition in generics

market

Highly regulated industries

Products are highly

immitigable

Price of row material

fluctuate highly

Page 5: Gcsr SEM 4

B. Products of the company:

Product

Name

Composition Photograph

Artequin

Contains:

Amodiaquine Hydrochloride USP Equivalent to Amodiaquine Base 153.1 mg

12 Nos. Amodiaquine Capsule

Each Soft Gelatin Capsule Contains:

Artesunate 50 mg

 Packing Style

12 + 12 Capsules

Mantra Plus

Contains:

Acetaminophen USP 500 mg

Caffeine USP 25 mg

Excipients Q.S.

Packing Style

1×10 Capsules

Emprofen 400

Contains:

Ibuprofen BP                 400 mg

Excipients                          Q.S.

Packing Style

1×10 and 10×10 Capsules

Page 6: Gcsr SEM 4

Emprofen

200

Contains:

Ibuprofen BP                 200 mg

Excipients                          Q.S.

Packing Style

1×10 Capsules

Parcamol

Forte

contains:

Acetaminophen 500 mg

Caffeine 25 mg

Packing Style

10 Capsules

Tegaferol

contains:

Alpha Lipoic Acid 100 mg 

Packing Style

10 x 10 Capsules

Helicoban

Contains:A. 2 Nos. OMEPRAZOLE CAPSULES Each soft gelatin capsule contains:Omeprazole BP 20.0 mgExcipients Q.S.

B. 2 Nos. CLARITHROMYCIN CAPSULESEach soft gelatin capsule contains:Clarithromycin USP 250.0 mgC. 2 Nos. TINIDAZOLE CAPSULESEach soft gelatin capsule contains:Tinidazole BP 500.0 mg

Packing Style 7 x (2+2+2) Capsules

C. Market Analysis & Marketing Plan

Page 7: Gcsr SEM 4

Segmentation

There are five major segments in GLPL.

1. Anti- Bacterial

2. Anti-Malarial

3. Haematinics

4. Pain Management

5. Herbal Formulation

4Ps analysis

Page 8: Gcsr SEM 4

Product

Artequin

Price

Place

South Africa, Nigeria, Morocco

Promotion

1. Publish their brochure in countries

market

2. Publish their calendar in the market

3. Campaign near hospital and health care

centre

4. Distribution of Complementary gifts

Import/export policies & procedures for selected product/service.

Page 9: Gcsr SEM 4

1. Import/Export Norms

Legal considerations

All transactions concerning the importation of consignments of pharmaceutical products should

be conducted through Ministry of Health, mission hospitals, any other person authorised by the

DRA or through independent authorised pharmaceutical importers licensed by the relevant drug

regulatory authority for this purpose.

The importation of all consignments of pharmaceutical products should be channelled

exclusively through the designated ports of entry and will be cleared by customs in consultation

with the inspectorate of the respective DRA.

An application for the issue of an import or export permit shall be made by an authorised

importer to the respective Drug Regulatory Authority in a prescribed form.

An applicant for an import permit must be in possession of an import licence issued by the

relevant drug regulatory authorities. The validity of the licence shall be determined by the

respective Drug Regulatory Authority. The Pharmaceutical Import Licence shall be subject to

renewal upon expiry.

No importation or exportation of pharmaceutical products shall be done by post.

The importation and exportation of Medicines and Scheduled substances are subject to control in

terms of the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as

amended. South Africa is also a signatory to three International Drug Conventions, namely:

• The Single Convention on Narcotic Drugs, 1961;

[The Medicines Control Council is responsible for implementing the measures required by the

said convention]

• The Convention on Psychotropic Substances, 1971; and

[The Medicines Control Council is responsible for implementing the measures required by the

said convention]

Page 10: Gcsr SEM 4

• The United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic

Substances, 1988.

[The Department of Trade and Industry is responsible for implementing the measures required

by the said convention]

Implementation of controls

The drug regulatory authorities shall provide comprehensive and frequently updated lists of

licensed or notified medicinal products and authorised dealers/importers which should be easily

accessible to designated ports of entry and authorised dealers. Notifications on any product

licences that have been withdrawn on grounds of safety or quality and confirmed cases of

imported counterfeit products and other illicit activities should immediately be communicated to

all the DRAs.

Customs officials in collaboration with a pharmaceutical inspector will carry out physical

examination of all imported consignment of medicinal products and their documentation.

Where necessary, the pharmaceutical inspector will carry out random sampling of

pharmaceutical products in accordance with laid down guidelines on sampling of medicinal

products imported into the country for drug analysis.

Consignments of pharmaceutical products should be accorded high priority for clearance through

ports of entry. Since pharmaceutical products tend to degrade on storage and some need to be

kept in cold storage, ports of entry need to be provided with secure storage facilities including

refrigerated compartments.

The authorised importer should alert customs officials in advance of the anticipated arrival of

consignments in order that they can be transferred to the designated storage facilities without

breaking the cold chain.

Page 11: Gcsr SEM 4

Required Documents

The import and export authorisations shall contain at least the following

information:

name of controlled substance(s) (if available, the International Nonproprietary Name)

quantity to be imported/exported expressed in terms of anhydrous base content.

name & address of the importer and exporter.

period of validity of the authorisation.

route of entry/exit through which importation/exportation shall be effected.

number and date of the corresponding import/export authorisation and the name of the

competent authorities of the importing/exporting countries by whom it was issued.

strength and dosage form.

An application for a licence to import/export controlled substances will be made to the respective

Drug Regulatory Authorities in the prescribed form backed by legislation.

Criteria for issue of authorisation to import

there are suitable premises, facilities and equipment for proper pharmaceutical

warehousing.

there are suitably qualified pharmaceutical personnel that shall oversee the quality

assurance i.e. pharmacist and pharmacy technologist/technician.

there are suitable arrangements, programmes and systems for procurement, storage,

documentation, stock surveillance and distribution.

Page 12: Gcsr SEM 4

Application for issue of an import permit

An application accompanied by a prescribed fee for issue of an import permit shall be made on

the prescribed form backed by legislation.

An application for issue of an import permit shall state, for each medicine to be imported at least

the following:

generic name or International Non-proprietary Name (INN)

strength and dosage form

name and strength of each ingredient; in case of a product containing more than

one ingredient

trade name or proprietary name; if any

pharmacopoeia specification of the medicine, where applicable

total quantity to be imported

name and address of the supplier

name and address of the manufacturer

country of origin

route of entry

licence/ registration number

cost, insurance, freight (CIF) value

expected date of arrival

A separate import permit for controlled substances will apply as prescribed by the national

legislation and applicable treaty obligations. The application shall be accompanied by copies of

the proforma invoices.

Page 13: Gcsr SEM 4

Application for issue of an export permit

An application accompanied by a prescribed fee for issue of an export permit shall be made on

the prescribed form backed by legislation. An application for issue of an export permit shall

state, for each medicine to be exported at least the following:

generic name or International Non-proprietary Name (INN)

strength and dosage form

name and strength of each ingredient; in case of a product containing more than

one ingredient

trade name or proprietary name; if any

pharmacopoeia specification of the medicine, where applicable

total quantity to be exported

name and address of the exporter

name and address of the manufacturer

name and address of consignee

country of consignee

route of dispatch

licence/registration number

cost, insurance, freight (CIF) value

expected date of dispatch

The application shall be accompanied by copies of the purchase orders.

In conclusion, importation of drugs that lack approval and are not in line with these guidelines

whether for personal use or otherwise will be considered as illegal importation and could be

refused entry into any of the SADC countries or seized by customs officials.

Page 14: Gcsr SEM 4

Licence No.

Registration No.

Pharmaceutical Import Licence

Messrs (Name of Importer)………………………………………………………………….........

………………………………………………………………………………………………………

……………………………………..

of (address i.e. Plot No. Street/Road, Town/City. P.O. Box) ……………………….…..

……………………………………..

………………………………………………………………………………………………………

…………………...…..…..…..

…………………………………………………………………………………………………….

………………………….…………………...

Carrying on business as ………………………………………………..….………….

……………..…………………… ………...

Are hereby authorised to Import Pharmaceutical Products (Medicines, herbal medicines

and allied substances) into the Country during the calendar year……………………..

…………………..……………………………………….……………..

Name of Supervising Pharmacist …………………………………………………..

Registration Certificate No: ………………………………………………..

Conditions imposed by the Pharmaceutical Regulatory Authority (refer to notes overleaf).

This licence is valid from……….. to…

………………. ……………..

Registrar of medicines Date stamp

Date Issued ………………………….

Page 15: Gcsr SEM 4

Licence No.

Registration No.

Pharmaceutical Export Licence

Messrs (Name of Exporter)……………………………………………………………… ……..

……………….

………………………………………………………………………………………………………

……………………………………..

of (address i.e. Plot No. Street/Road, Town/City. P.O. Box)…………………….

…………………………………………………..……………………………………………….

………………………………………………………………………………………………………

………………………………………………………………..

…………………………………………….…………………...

Carrying on business as ……………………… ……………………………………….

……………..………………………………...

Are hereby authorised to export Pharmaceutical Products (Medicines, herbal medicines

and allied Substances) during the calendar year…………………………..

……………………………………….……………..

Name of Supervising Pharmacist …………………………………………………..

Registration Certificate No: ………………………………………………..

Conditions imposed by the Drug Regulatory Authority (refer to notes overleaf).

This licence is valid from…………. to………….………………….

………………. ……………..

Registrar of medicines Date stamp

Date Issued …………….……